Kornimate/medical-research-clean huggingface dataset:
hematogenous osteomyelitis in childhood can relapse dozens of years in adulthood

Conditions: Osteomyelitis; Hematogenous Osteomyelitis Relapse

Summary: to our knowledge, few cases of relapse in adulthood are described in the literature except in patients with sickle cell disease and the epidemiological, clinical, laboratory, radiological features and the management of osteomyelitis relapsing in adulthood are not described. the aim of this retrospective multicentric cohort study : in france is to describe the epidemiological, clinical, laboratory, and radiological features and the management of adult patients who experienced a relapse between 2003-2015 of an acute hematogenous osteomyelitis acquired in the childhood (description of characterization of the period between the first episode of osteomyelitis and the second episode, description of signs of relapse and description of treatments used in the relapse). the data are analysed with non-comparative descriptive statistics.


Eligibility criteria:
inclusion criteria: * adult patients (≥ 18 years) who presented a relapse between 2003-2015 of a hematogenous osteomyelitis acquired in childhood. * the time limit between the 2 episodes must be at least 2 years * antecedent of osteomyelitis before 16 years exclusion criteria: * inability to give the information to the patient * patients opposed to the use of their data

Keywords: hematogenous osteomyelitis relapse adulthood
cpap in-home assessment nz

Conditions: Obstructive Sleep Apnea

Summary: phase 1:the study is to evaluate the product reliability, therapy effectiveness and user feedback of a continuous positive airway pressure (cpap) device in-home for up to 6 months. phase 2: to evaluate the cpap device with communication functionality with data upload.

phase 1:existing and naïve cpap users will be recruited into a 6 month in-home study participants will attend 5 study visits at day 0, 7, 30, 60 and 180. outcome of the clinical investigation include downloadable device data reports, device error reports and participants perception questionnaires. phase 2: 10 participants from phase 1 will be recruited to use the device for up to 6 month in-home. participants will attend 3 study visits at day 0, 7 30. the trial may be extended to 60 days if longer term data is required.

Eligibility criteria:
inclusion criteria: * aged 18 and over * diagnosed with obstructive sleep apnea (osa) and prescribed positive airway pressure (either continuous positive airway pressure (cpap) or autocpap) * be fluent in spoken and written english exclusion criteria: * contraindicated for positive airway pressure (cpap or autocpap) therapy * persons with other significant sleep disorder(s) (e.g periodic leg movements, insomnia, central sleep apnea) * persons with obesity hypoventilation syndrome or congestive heart failure * persons that require supplemental oxygen with their positive airway pressure (cpap or autocpap) device. * persons with implanted electronic medical devices (e.g cardiac pacemakers) * persons who are pregnant or think they may be pregnant.
buprenorphine transdermal system (btds) in subjects with moderate to severe chronic low back pain

Conditions: Low Back Pain

Summary: the objective of this study is to determine the analgesic efficacy and safety of buprenorphine transdermal system (btds) 10 and 20 compared to placebo in opioid-naïve subjects with moderate to severe chronic low back pain. the double-blind treatment intervention duration is 12 weeks, during which time supplemental analgesic medication (immediate-release oxycodone for the first 6 days post-randomization and acetaminophen or ibuprofen for the remainder of the double-blind phase) will be provided to all subjects in addition to study drug.

buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic settings for the relief of moderate to severe pain. btds is a transdermal system formulation that is designed to deliver a consistent and a steady dose of buprenorphine over a 7-day period with limited blood concentration fluctuation.

Eligibility criteria:
inclusion criteria: * subjects with moderate to severe chronic low back pain (lasting several hours daily) as their predominant pain condition for at least 3 months prior to screening, * subjects treated within the 14 days prior to screening with nonopioid therapy only, or with therapy including opioids at a dose of \<5 mg oxycodone (or equivalent) per day, * subjects whose low back pain is not adequately controlled with non-opioid analgesic medication and who the investigator feels are appropriate candidates for around-the-clock opioid therapy exclusion criteria: * subjects who had a surgical procedure directed towards the source of back pain within 6 months of screening or planned during the study conduct period, * subjects who are allergic to buprenorphine or who had a history of allergies to other opioids, * subjects who have allergies or other contraindications to transdermal delivery systems or patch adhesives. other protocol-specific inclusion/exclusion criteria may apply.

Keywords: chronic pain opioid transdermal moderate to severe chronic low back pain
psycho-educational and rehabilitative intervention for cancer cachexia (pricc)

Conditions: Cancer Cachexia

Summary: half of all cancer patients experience cachexia, with the prevalence rising above 80% in the last weeks of life. the cancer cachexia is a complex relational experience which involves the dyads patients-families. there are no studies on psychosocial interventions on dyads associated with rehabilitative interventions, to support more functional relationships to the management of cancer cachexia. primary objective: to evaluate the feasibility of a psycho-educational intervention combined with a physiotherapy intervention on the dyads. secondary objective: improvement of the quality of life of dyads, acceptability of the intervention, adherence to each of the two components. methods: non-pharmacological interventional perspective, mixed-method study, addressed to a consecutive 30 cancer patients with cachexia and irreversible cachexia and their caregivers assisted by hospital palliative care unit.


Eligibility criteria:
inclusion criteria: * age of 18 years or older * good command of the italian language * written informed consent * histologically confirmed tumor diagnosis * presence of irreversible cachexia and cachexia (espen3-5 guidelines, must calculation) * patients who have identified a caregiver * patients and family members are informed of the diagnosis and the objectives of the therapies and who have reported awareness of the disease phase (evaluated by the palliative doctor). exclusion criteria: * patients with prognosis less than three months to enable the rehabilitative intervention * presence of important mental disorder or dementia * severe sensory deficit * presence of diffuse bone metastases that put the patient at risk of fracture during rehabilitation exercise.

Keywords: cancer cachexia psychoeducational intervention rehabilitative intervention dyad palliative care
prospective, randomized, open label controlled trial to evaluate the safety and efficacy of dexmedetomidine use beyond 24 hours compared with midazolam in children admitted to pediatric intensive care unit at king abdullah specialist children hospital- ministry of national guard health affairs.

Conditions: Dexmedetomidine; Midazolam; Withdrawal Symptoms; Failure of Extubation

Summary: study will be conducted in pediatric intensive care unit (picu) in king abdullah specialist children hospital (kasch), national guard health affairs, riyadh, saudi arabia. total of 430 patients will participate to assess the safety and efficacy of prolonged dexmedetomidine use beyond 24 hours in pediatric intensive care unite.

prospective, randomized, open label, controlled study, will be conducted in pediatric intensive care unit (picu) in king abdullah specialist children hospital (kasch), national guard health affairs, riyadh, saudi arabia. 340 patients will be randomly randomized to midazolam (m) or dexmedetomidine (d), to assess the safety and efficacy of prolonged dexmedetomidine use beyond 24 hours.

Eligibility criteria:
inclusion criteria: 1. age 1-14 years both male and female who require mechanical ventilation 2. informed consent from signed by patient's legal representatives, and for patients aged 12- 14 who has an age-appropriate understanding additional assent form signed by patient is required. 3. intubated within 6 hours and anticipated to require mechanical ventilation for more than 48 hours exclusion criteria: 1. septic shock and/or multi-organ failure. 2. hemodynamically instability and requires inotropes. 3. severe intracranial or spinal trauma with high intracranial pressure 4. liver failure 5. acute or chronic renal failure. 6. glasgow coma scale (gcs) ≤8 7. known to have allergy to the study drugs 8. airway surgery

Keywords: dexmedetomidine midazolam intubation withdrawal symptoms failure of extubating
the predictive value of proteome profiling for brain metastasis in limited-stage small-cell lung cancer

Conditions: Small-cell Lung Cancer

Summary: this study aims to evaluate the predictive value of proteome profiling for brain metastasis in limited-stage small-cell lung cancer

small-cell lung cancer (sclc) constitutes approximately 15% of all lung cancer cases and is characterized by a highly aggressive disease course and poor prognosis. the brain is the most common metastatic site of sclc, and it is also an important cause of high mortality. more than 20% of sclc patients have developed brain metastasis (bm) at the first diagnosis. prophylactic cranial irradiation (pci), as an essential part of the treatment of limited-stage small-cell lung cancer (ls-sclc), inevitably leads to neurotoxicity. therefore, there is an urgent need for a convenient and effective prediction model to realize the early prediction of sclc brain metastasis. patients at high risk of brain metastases were treated with individualized pci. in the current study, the investigators have analyzed the proteome profiling using data-independent acquisition mass spectrometry (dia-ms) method in formalin-fixed paraffin-embedded (ffpe) tissues from patients with limited-stage small-cell lung cancer. the prognostic biomarkers were developed based on machine learning in the non-pci group. patients in the non-pci group were classified into modeling cohort and external validation cohort . furthermore, the prognostic value of the candidate biomarkers be evaluated in a prospective cohort . based on the brain metastasis model, patients were divided into high- and low-risk groups. the benefit value of pci was analyzed in high-risk and low-risk groups.

Eligibility criteria:
inclusion criteria: 1. age \> 18 years old 2. histological / pathologic proved limited-stage small-cell lung cancer 3. achieved a complete response (cr) or partial response (pr) after first-line crt exclusion criteria: 1. simultaneous participation in another clinical trial 2. brain mri was not performed during treatment and follow-up 3. the follow-up time was less than 2 years 4. patients presenting with other known malignancies for which they are receiving treatment
effects of 'pinkwashed' alcohol ads in an online rct

Conditions: Breast Cancer; Cancer

Summary: the primary objective of this study is to examine how exposure to "pinkwashed" alcohol advertisements (i.e., ads that associate the company with breast cancer awareness or charities) affects consumers' perceptions that alcohol increases the risk of breast cancer. the investigators will randomize participants to view 3 'pinkwashed' social media advertisements for alcohol or 3 control advertisements for alcohol (i.e., 'de-pinked' standard alcohol advertisements that match the intervention advertisements on overall design but do not mention breast cancer). each participant will view the 3 advertisements for their arm (presented in random order) and respond to survey questions programmed in qualtrics.


Eligibility criteria:
inclusion criteria: * 18 years old or older exclusion criteria: * less than 18 years old
trial comparing duration of analgesia after popliteal fossa sciatiac nerve block with ropivacaine 0.5% when combined with placebo, dexamethasone 4mg or dexamethasone 8 mg

Conditions: Pain, Sciatic Block

Summary: the purpose is to find out if the addition of dexamethasone to ropivacaine 0.5% increases the duration of pain relief provided by popliteal sciatic nerve block performed for foot/ankle surgery. the investigators also want to find out if there is a difference between 4 and 8 mg dose of dexamethasone.


Eligibility criteria:
inclusion criteria: * ages 18-64 * asa physcial status classification 1-3 * foot and ankle surgery at ben taub general hospital exclusion criteria: * diabetes mellitus * peripheral neuropathy * coagulopathy * allergy to study drugs * systemic glucocorticoid treatment (for 2 weeks or more) within 6 months of surgery * chronic opioid use at home * patient inability to properly describe pain to investigators * pregancy * prisoners * patient or surgeon refusal

Keywords: pain ropivacaine sciatic block dexamethasone
safety and tolerability of autologous adipose-derived mesenchymal stem cells therapy in adults with atrophic scars

Conditions: Atrophic Scar

Summary: the purpose of this clinical trial was to evaluate the safety and tolerability for 12 weeks after one dose of trtp-101 in adults with atrophic scars.

a phase 1 clinical trial to evaluate dose-limiting toxicity by administering a singe dose of trtp-101 to each of the four sites of atrophic scar.

Eligibility criteria:
inclusion criteria: 1. male or female aged greater than 19 years 2. four or more atrophic scars in the joints, genitals, perineum, and face except for the lips, eyes and nose exclusion criteria: 1. history of cell therapy 2. treatment of dermal resurfacing, chemical/mechanical peel and skin photorejuvenation 3. treatment of hyaluronic acid/collagen skin filler, non-permanent soft tissue filler and fat grafting 4. positive for virus infection 5. use of anticoagulant therapy or nsaids 6. thrombocytopenia or other coagulation disorder 7. history of keloid scars 8. infectious disease or other dermatitis in the area of the atrophic scar 9. use of immunosuppressant, immunomodulating drug, anticancer drug or radiation therapy 10. use of systemic steroid medication 11. history of hypersensitivity or severe allergic reactions (e.g., anaphylaxis, guillain-barre syndrome, etc.) 12. use of retinoid medications
can novel oxygenation indices guide the diagnosis of acute respiratory distress syndrome

Conditions: Respiratory Distress Syndrome, Adult

Summary: this study aims to determine the cut-off values of the new oxygenation indices and further investigate their capabilities in diagnosing ards and predicting its severity in icu. additionally, the investigators aim to compare these results with conventional oxygenation and saturation indices.

recent studies have shown that mechanical power (mp) values below 17 j/min and driving pressure (dp) values below 15 cmh2o reduce intensive care unit (icu) mortality. asar et al. have introduced six new oxygenation indices utilizing mp and dp instead of pmean (osi-mptot, oi-mptot, osi-δpinsp, oi-δpinsp, osi-mpdyn, oi-mpdyn). they compared the predictive abilities of these new indices for icu mortality in covid-ards (c-ards) patients with conventional oxygenation indices (p/f, spo2/fio2, oi, osi, pao2/(fio2xpeep), and spo2/fio2xpeep). oi-δpinsp, osi-δpinsp, and osi-mpdyn indices exhibited the highest predictive power for icu mortality. however, cut-off values for the diagnosis and severity determination (mild, moderate, and severe) of ards patients have not been investigated. in this study, our objective is to determine the cut-off values of the new oxygenation indices and further investigate their capabilities in diagnosing ards and predicting its severity in icu. additionally, the investigators aim to compare these results with conventional oxygenation and saturation indices.

Eligibility criteria:
inclusion criteria: 1. patients admitted to intensive care units diagnosed with ards / c-ards according to the berlin criteria. 2. adult patients aged between 18 and 80 years exclusion criteria: 1. patients under the age of 18 2. pregnant patients 3. patients without ards 4. patients with missing data 5. patients transferred to another hospital 6. patients discharged from the icu within 72 hours 7. patients receiving extracorporeal membrane oxygenation (ecmo) support. 8. patients were on mechanical ventilation for less than 24 hours
inhaled corticosteroids (ics) on pulmonary endothelial function in copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the study objective is to determine whether an ics added for 4 weeks to a baseline treatment with a long-acting beta-adrenergic agonist (laba) and long-acting muscarinic antagonist (lama) combination improves pulmonary vascular endothelial function as assessed by the vasodilator response to inhaled albuterol (endothelium-dependent vasodilation) in stable copd patients treated with a laba/lama without an ics for at least one month.


Eligibility criteria:
inclusion criteria: * physician diagnosis of copd * former smoking history of more than 10 pack-years * baseline post-bronchodilator one-second forced expiratory volume (fev1) 50-80% of predicted, baseline fev1 and forced vital capacity (fvc) ratio \<0.7 * males and females, 40-80 years of age * regular use of a lama/laba drug regimen for at least a month exclusion criteria: * women of childbearing potential who do not use accepted birth- control measures * pregnant and breast-feeding women * respiratory infection within 4 weeks of a test day * a corona virus disease (covid) vaccination \<3 months prior to study entry * ics use (within 4 weeks of study entry) * ics hypersensitivity * albuterol intolerance * use of beta-blocker medication (oral and ophthalmic) * use of systemic glucocorticosteroid medication within 6 wk prior to the screening visit * an acute copd exacerbation within 6 wk of the screening day (defined as a need for antibiotic or systemic glucocorticoid therapy or emergency department (ed) visit/hospitalization) * current smoking or vaping tobacco or other products * oxygen (o2) saturation of \<90% at-rest breathing room air * long-term oxygen therapy (ltot) required at rest * regular use of pulmonary vasodilators * systemic arterial systolic pressure \>150 mmhg and diastolic pressure \>100 mmhg on the test day * a \>40mmhg right ventricular systolic pressure (rvsp) by prior echocardiography * a documented covid infection within 4 weeks of the screening day * regular use of home oxygen at rest * physician diagnosis of obesity hypoventilation syndrome
silybin supplementation during hcv therapy with pegylated interferon-α2b plus ribavirin reduces depression and increases work ability

Conditions: Work Ability; Depression

Summary: background: hepatitis c virus infection and interferon treatment have shown to be risk factors for depression, distressing, psychosocial burden and poor health-related quality of life. aim: to determine the effect of a sylibin-vitamin e-phoshpolipids complex on work ability and whether health related factors (anxiety and depression) were associated with work ability in subjects with chronic hepatitis c treated with peg-ifn-α and rbv. patients and methods: in this prospective, randomized, placebo controlled, double blind clinical trial, 31 subjects (group a) with chronic hepatitis, received pegylated-interferon-α2b (1.5 mg/kg per week) plus ribavirin and placebo, while 31 subjects (group b) received the same dosage of pegylated-interferon-α2b plus ribavirin plus association of silybin 94 mg + vitamin e 90 mg + phospholipids 194 mg in one pill for 12 months. all subjects underwent laboratory exams and questionnaires to evaluate depression (beck depression inventory - bdi), anxiety (state-trait anxiety inventory - stai) and work ability (work ability index - wai).


Eligibility criteria:
inclusion criteria: * hcv infection exclusion criteria: * cancer severe jaundice pulmonary and renal chronic diseases prostatic diseases autoimmune diseases diabetes mellitus decompensated cirrhosis pregnancy hemoglobinopathies hemocromatosis
maternal and infant growth study

Conditions: Maternal Behavior; Body Weight; Infant Behavior

Summary: rapid growth early in infancy is a risk factor for obesity and cardiovascular disease later in the lifespan. evidence is limited, but both pre- and postnatal factors are associated with early rapid growth, and include high maternal bmi prior to pregnancy and excessive gestational weight gain. this research focuses on aspects of early feeding as potentially modifiable factor affecting early infant weight gain. formula feeding mothers are randomized to receive either 5 oz of 8 oz bottles to use in feeding their infants from 2- to 16 weeks postpartum. in addition, a reference group of exclusively breastfeeding mother-infant dyads are also included. the hypothesis is that differences in feeding practices will be associated with differences in growth and that infants randomized to be fed from smaller bottles will grow more slowly that those randomized to larger bottles. growth patterns of formula fed infants will also be compared to those of exclusively breastfed infants.

mothers complete feeding logs, questionnaires on health history, demographics, feeding attitudes and practices. infant growth and body composition are measured via pea pod, and maternal anthropometrics and body composition are measured in bod pod the laboratory at 2, 8, and 16 weeks postpartum. primary outcome is change in weight-for-age z-scores.

Eligibility criteria:
inclusion criteria: * pregnant or newborn aged 28 days or younger exclusion criteria: * gestational diabetes, hypertension, pregnancy/delivery complications, premature birth, low birth weight

Keywords: infant feeding infant growth
repeat surgery for patients with post-operative trachomatous trichiasis trial

Conditions: Trichiasis; Surgery

Summary: the objective of this study is to determine if there is a significant difference in post-operative trichiasis at 12 months comparing a new procedure, the bevel/rotate/advance procedure (brap), to the trabut procedure among repeat surgery patients.

the investigators will randomize participants with previously operated trichiasis on a 1:1 basis to receive either the bevel/rotate/advance procedure (brap) or the trabut procedure. the participants will be followed at 1 day, 2 weeks, 3-6 months, and then 12 months following the surgery. the primary study endpoint is recurrence of post-operative trichiasis within 12 months of surgery. the investigators will conduct logistic regression analysis comparing post-operative trichiasis recurrent rates in participants receiving brap versus participants receiving trabut. adjusted analyses will account for demographic characteristics as well as trichiasis severity prior to surgery.

Eligibility criteria:
inclusion criteria: * aged 18 or older * at least one eyelid with post-operative upper eyelid trichiasis * willing to comply with all study procedures and be available for the duration of the study exclusion criteria: * inability to provide independent, informed consent